Regulatory Research Agencies


Last updated: December 6, 2007

The National Institute of Allergy and Infectious Diseases (NIAID) is a division of the National Institutes of Health (NIH) within the US Department of Health and Human Services (HHS) mandated to conduct and support “research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases.” Since its inception in 1948, NIAID has invested heavily in basic and applied biomedical research. Following the events of Sep. 11, 2001, NIAID took on an additional role as the lead US agency for developing and testing the safety and efficacy of vaccines and other medical countermeasures to bacterial, viral, and other diseases that could be used as biological weapons. NIAID’s annual budget for civilian biodefense has grown from $53 million in 2001 to more than $1.6 billion in 2007.


Animal Use Activities

In the context of biodefense, NIAID has initiated an aggressive intramural research program to study nearly 50 deadly diseases that could be used as agents of bioterror. The NIAID research agenda is divided into two parts, according to the relative public health hazard posed by various agents, as defined by Centers for Disease Control and Prevention. Specifically:

  • Category A agents (e.g., anthrax, plague, smallpox, botulism, tularemia, and viral hemorrhagic fevers such as Ebola) are considered to pose the greatest risk to national security and have therefore been assigned the highest priority for study and countermeasure development
  • Category B and C agents (e.g., brucellosis, ricin toxin, and emerging diseases such as Nipah virus and hantavirus) are generally less pathogenic and may be more difficult to weaponize or disseminate, resulting in a somewhat lower level of concern

For each of the nearly four-dozen agents listed in its biodefense research agenda, NIAID reports that it has established comprehensive in-house programs of study and medical countermeasure development, including the following areas of definite or probable animal use:

  • Basic biology, to understand how microbes and their toxic products function and cause disease
  • Immunology and host response, to understand how the human immune system interacts with and defends the body against potential bioterrorism agents
  • Vaccine production, to create new and improved vaccines by working closely with industry
  • Drug development, to develop and test drugs to treat diseases that may result from a biological attack by closely working with the pharmaceutical industry

In addition to the intramural biodefense research program under way at NIAID, extensive funding is also made available for extramural research at universities, hospitals and other institutions by means of grants, cooperative agreements, and government contracts.


Alternatives Policies & Actions

Although the preponderance of biodefense and other infectious disease research at NIAID is very likely animal-based, the agency reports that it has developed in vitro screens for a handful of pathogens.